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Orally disintegrating tablets containing lurasidone and preparation method thereof

A technology of orally disintegrating tablets and lurasidone hydrochloride, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., can solve the problems of poor dissolution in vitro and bad taste, and improve compliance , avoid fake medicine, the effect of simple preparation process

Active Publication Date: 2014-01-29
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] In order to solve the problems existing in the prior art, the present invention provides an orally disintegrating tablet containing lurasidone hydrochloride, which effectively solves the poor in vitro dissolution and bad taste of lurasidone hydrochloride orally disintegrating tablets The problem

Method used

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  • Orally disintegrating tablets containing lurasidone and preparation method thereof
  • Orally disintegrating tablets containing lurasidone and preparation method thereof
  • Orally disintegrating tablets containing lurasidone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Example 1: Liquidity detection of lurasidone hydrochloride

[0056] According to the above-mentioned fluidity detection method, the fluidity of lurasidone hydrochloride was determined, and the results are as follows:

[0057] The angle of repose of D90≤250um powder is 39.7°;

[0058] The angle of repose of D90≤75um powder is greater than 60°, about 60-80°, the result is poor in repeatability;

[0059] D90≤30um powder cannot pass through the funnel, and the angle of repose cannot be detected.

Embodiment 2

[0060] Example 2 Preparation of orally disintegrating tablets by wet granulation process

[0061] Lurasidone hydrochloride is a white or off-white powder with poor fluidity and a bitter taste, making it difficult to prepare orally disintegrating tablets with good taste. Through a large number of experiments, the inventors were surprised to find that when pH-dependent soluble materials such as acrylic resin E100 and acrylic resin EPO are used as binders, first granulating lurasidone hydrochloride alone or with part of the auxiliary materials can be very good Solve the problem of fluidity and bitterness of this product. When using conventional binder materials, such as povidone k30, hypromellose, ethyl cellulose, 70% ethanol, etc., as the binder of the present invention, although it can solve the problem of poor fluidity, Can not effectively conceal the bitter taste of disintegrating tablets.

[0062] This experiment uses the prescription: Lurasidone hydrochloride (D90≤75um) 26.7%,...

Embodiment 3

[0068] Example 3 Preparation of orally disintegrating tablets by direct compression of powder

[0069] The powder direct compression method has the advantages of simple process, energy saving and time saving, and is conducive to continuous and automated production. But this process has higher requirements on the fluidity, compressibility and lubricity of the material. In order to meet the requirements of oral disintegration and improved compliance, the material must also have good disintegration or dissolution properties, and a good taste. The challenge is: Lurasidone hydrochloride raw material has poor fluidity and is difficult to dissolve in water. A large amount of fillers must be used to improve it. This may bring about the consequences of large tablets and a large number of tablets. The need to improve the compliance of mental patients with medication is contradictory.

[0070] The inventor investigated the feasibility of direct compression of the powder of lurasidone hydroc...

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Abstract

The invention relates to orally disintegrating tablets containing lurasidone and a preparation method thereof. The orally disintegrating tablets comprise lurasidone hydrochloride, filler, disintegrant, flavoring agent and lubricant, wherein the grain diameter D90 of the lurasidone hydrochloride is less than or equal to 75 mu m. The lurasidone orally disintegrating tablets have good dissolution in vitro and excellent taste; the orally disintegrating tables are simple in preparation process, and industrial production can be realized by adopting conventional granulation and tabletting equipment.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations. Specifically, it relates to an orally disintegrating tablet containing lurasidone and a preparation method thereof. Background technique [0002] Schizophrenia (schizophrenia) is a common mental illness whose etiology is not fully elucidated. It often occurs in young adults and often suffers from obstacles in perception, thinking, emotion, and behavior. It is generally unconscious and mentally disabled. The course of the disease is protracted, accounting for more than half of the inpatients in the psychiatric department. In the end, about half of the patients have mental disability, which brings a serious burden to the society, patients and their families [Shu Liang.Guidelines for prevention and treatment of schizophrenia[M].Beijing: Peking University Medical Press, 2009:3.]. [0003] Lurasidone hydrochloride is N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene -Bu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61P25/18
CPCA61K9/0056A61K9/2018A61K9/2095A61K31/496
Inventor 柯潇郑强
Owner CHENGDU KANGHONG PHARMA GRP
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